Evidence map›Paper›PMID 33435908›Full record

Observational studyBMC ophthalmology2021

Sub-optimal gain in vision in retinal vein occlusion due to under-treatment in the real world: results from an open-label prospective study of Intravitreal Ranibizumab.

Raja Narayanan, Aditya Kelkar, Zahir Abbas, Neha Goel, Manoj Soman, Naveen Naik, Aditya Sudhalkar, Jaydeep Walinjkar, Utkarsh Shah, Nitin Maksane

Open access · goldAbstract readObservational Study
PubMed Full text at PMC Publisher
In one paragraph

Observational study in BMC ophthalmology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
1.7field-weighted citation impact, top 18% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 15 citations in OpenAlex.

  1. Observational
  2. Review
  3. Article
  4. Article
  5. Article
  6. Article
  7. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 8 institutions in 1 country.

Raja NarayananL V Prasad Eye Institute, Hyderabad Eye Research Foundation, Hyderabad, Telangana, India. narayanan@lvpei.org.ORCID http://orcid.org/0000-0001-9688-5859
Aditya KelkarNational Institute of Ophthalmology, Pune, Maharashtra, India.
Zahir AbbasApollo Gleneagles Heart Centre, Kolkata, West Bengal, India.
Neha GoelICARE Research Center, Noida, Uttar Pradesh, India.
Manoj SomanChaithanya Eye Hospital, Trivendrum, Kerala, India.
Naveen NaikNarayana Nethralaya, Bengaluru, Karnataka, India.
Aditya SudhalkarIladevi Cataract & IOL Research Centre, Ahmedabad, Gujarat, India.
Jaydeep WalinjkarSankara Nethralaya, Chennai, Tamilnadu, India.
Utkarsh ShahNovartis Healthcare Private Limited, Mumbai, Maharashtra, India.
Nitin MaksaneNovartis Healthcare Private Limited, Mumbai, Maharashtra, India.
Novartis (India) · INApollo Gleneagles Hospitals · INChaithanya Eye Hospital and Research Institute · INICARE Eye Hospital & Postgraduate Institute · INICMR-National Institute of Virology · INL V Prasad Eye Institute · INNarayana Nethralaya · INSankara Nethralaya · IN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMacular edema secondary to retinal vein occlusion (RVO) is an important cause of loss of vision. Intravitreal injections (IVI) of anti-vascular endothelial growth factor (VEGF) are the standard of care in this disease, as shown in numerous randomized controlled trials. The purpose of this study was to study the efficacy and safety of ranibizumab, an anti-VEGF agent, in the real-world setting.

methodsThis was 48 weeks, open-label, prospective, multicentre, observational study. Patients diagnosed with ME secondary to RVO were treated with IVI of Ranibizumab 0.5 mg in real-world conditions. Efficacy was measured by improvement seen in best-corrected visual acuity (BCVA) in terms of Early Treatment of Diabetic Retinopathy Study (ETDRS) Letter Scores and change in central retinal thickness (CRT) measured by optical coherence tomography.

resultsOne hundred eyes of 100 patients (79 with branch retinal vein occlusion and 21 with central retinal vein occlusion) were recruited in the study. The mean (standard deviation, SD) BCVA was 52.8 (21.99) letters at baseline and 62.3 (24.40) letters at week 48. From baseline, there was a significant improvement in BCVA by 7.7 letters (p = 0.001) at 48 weeks. The mean (SD) of CRT was 479.9 (216.25) μm at baseline and it decreased significantly to 284.9 (171.35) μm at week 48 (p < 0.001). During the study period, the average number of intravitreal injections was 3.5 per patient. There was no report of endophthalmitis in any eye.

conclusionsRanibizumab is well tolerated and effective in treating macular edema secondary to RVO in real-world clinical settings. However, there is under-treatment compared to controlled clinical trials, and the gain in vision is sub-optimal with under-treatment.

trial registrationClinical Trials Registry - India: CTRI/2015/07/005985 .

Indexed as

Retinal Vein OcclusionAngiogenesis InhibitorsHumansIndiaIntravitreal InjectionsProspective StudiesRanibizumabTomography, Optical CoherenceTreatment OutcomeVisual AcuityAngiogenesis InhibitorsRanibizumabMacular edemaOpen label prospective studyRanibizumabRetinal vein occlusionVisual acuity

Identifiers

PMID33435908
PMCPMC7805171
OpenAlexW3119492218

What Socratic holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.